MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR, INC. TRIAGE CARDIAC TRIPLE MARKER PANEL; TRIAGE CARDIAC PANEL

Model Number 97000HS

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated with in-house testing of retain lot w63311b.No issues with myoglobin recovery were observed.Manufacturing batch records for lot w63311b were reviewed and found that the lot met final release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

Customer reported that their most recent correlation yielded higher myoglobin results on the triage system than the reference lab.2 comparisons were provided (customer unable to provide all results): triage myo=108, lab=46 , triage myo=262, lab= 94.Customer stated samples were collected in edta tubes.Whole blood was first tested on the triage system and then the samples were spun down to plasma and tested at the lab.Customer stated no issues with patient results and that they were not questioning any patient results.Customer stated they have two triage meters on site and both meters correlated well with each other (serial numbers and results not provided) despite multiple attempts customer was unable to provide myoglobin reference ranges for the triage and the reference lab.No triage myoglobin results were used to determine patient care.

• Brand Name: TRIAGE CARDIAC TRIPLE MARKER PANEL
• Type of Device: TRIAGE CARDIAC PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: jessica perrotte ; 9975 summers ridge road; san diego, CA 92121 ; 8588053573
• MDR Report Key: 7243282
• MDR Text Key: 99781222
• Report Number: 3013982035-2018-00003
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2018
• Device Model Number: 97000HS
• Device Lot Number: W63311B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1